Neurocrine Biosciences submits NDA for opicapone for Parkinson's disease based on existing pivotal clinical trial data.
M2 PHARMA-February 15, 2018-Neurocrine Biosciences submits NDA for opicapone for Parkinson's disease based on existing pivotal clinical trial data
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Biotechnology company Neurocrine Biosciences Inc (NASDAQ:NBIX) said on Wednesday that it will proceed with plans to file the NDA for opicapone for Parkinson's disease during the first half of 2019 based on existing pivotal clinical trial data.
The US Food and Drug Administration (FDA) has reportedly provided guidance on the regulatory path forward to support the company's New Drug Application (NDA) for opicapone for Parkinson's disease, following the productive meeting.
Opicapone, an investigational drug in the US, is a once-daily, peripherally-acting, highly-selective catechol-o-methyltransferase (COMT) inhibitor being developed as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors for adult patients with Parkinson's disease and motor fluctuations.
In 2017, Neurocrine had signed an exclusive licensing agreement with BIAL for the development and commercialisation of opicapone in the US and Canada. As a result of the US FDA guidance for the NDA filing, Neurocrine will pay a USD10m milestone payment to BIAL.
Based on the company's two pivotal Phase III studies, BIPARK-I and BIPARK-II demonstrated that opicapone once-daily achieved a statistically significant decrease in off-time periods for Parkinson's patients compared to placebo. The data from these two Phase III trials demonstrated that opicapone improved motor fluctuations in levodopa-treated patients regardless of concomitant dopamine agonist or monoamine oxidase type B inhibitors used.
Parkinson's disease is a chronic and progressive movement disorder that affects approximately one million people in the United States.
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|Date:||Feb 15, 2018|
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